GUEST COLUMNISTS

• Why We Need Pharmaceutical Engineering Project Management As A Distinct Discipline

  Applying general project management to a regulated setting as a variant of PMP or PRINCE2 is one of the most consistent, and most avoidable, causes of cost overrun and delayed start-up.

• Complete Response Letters For CGTs Share This Common Theme

  One expert’s analysis found CMC-related concerns in about 75% of complete response letters. He outlines a path to stronger CMC readiness for cell and gene therapies.

• Your 7 Decisions To Make Before MES Configuration

  Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.

• The Orange Book's Blind Spot: Process Stability And Capability

  The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.

• Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?

  With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.

• DEA Reveals Hidden Costs Of Analytical Validation Guidelines

  By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.

• Qualification And Validation Of Depyrogenation Tunnels And Autoclaves

  Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization. 

• FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters

  The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.